(and dosage form)
Miconazole nitrate 20 mg and benzoyl peroxide 50 mg per gram in a cream formulation.
A.13.12 Acne preparations.
Acnidazil has bactericidal, fungicidal and keratolytic properties. In vitro studies with Acnidazil demonstrate a synergistic mechanism of action in the inhibition of Staphylococcus spp. and Propionibacterium acnes.
Acnidazil is indicated for the treatment of acne vulgaris.
Hypersensitivity to any of the ingredients.
Systemic absorption after topical application of miconazole cannot be excluded. Since no data are available for benzoyl peroxide, Acnidazil should be used during pregnancy and lactation only if needed.
Patients who have sensitive skin or who have reacted adversely to other acne products should be advised to apply a small amount of cream to a small area of skin either behind or on the inner surface of the forearm and leave it for 24 hours. If severe irritation or pronounced redness occurs, they should be advised not to use the product.
DOSAGE AND DIRECTIONS FOR USE
FOR EXTERNAL USE ONLY.
A thin layer of cream should be applied to the affected areas once daily (evening) during the first week and twice daily (morning and evening) thereafter. Washing the face with mild soap and lukewarm water prior to application enhances the efficacy of the medication. The cream can be rubbed in gently with the fingertips.
Treatment should be continued until symptoms have disappeared (normally between 4 and 8 weeks). Then, especially in patients younger than 18 years of age, it is advisable to maintain the treatment with less frequent applications (2 - 3 times a week) to ensure improvement.
Patients with widespread facial acne should only apply Acnidazil to a small area for the first few days. If this is well tolerated, larger areas can then be treated.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
After application there may be transient stinging or burning sensations, which disappear after continued use. Vasodilation and perivascular lymphocytic infiltration occur. It is especially irritating to skin on the neck and circumoral areas. It must be kept away from the eyes and mucous membranes. Excess dryness of the skin and desquamation may occur after 1 or 2 weeks of use. Benzoyl peroxide can cause dermatitis.
The product may bleach dyed clothing and fabrics.
Mild irritation and/or moderate reddening may appear, especially at the beginning of treatment.
True contact allergy to benzoyl peroxide or miconazole may be encountered.
Avoid exposure to excessive sunlight and other sources of UV-light.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage or toxic effects are unlikely to occur after the ingestion of a small amount of active ingredients contained in a tube of cream. However, in the event of accidental ingestion an appropriate method of gastric emptying may be used if considered appropriate.
Excessive topical application can result in skin irritation and erythema. This adverse experience can be stopped by an interruption of treatment or a reduction in the frequency of application.
White, odourless cream.
Acnidazil cream is supplied in a tube containing 25 g of the cream.
Store below 25°C.
Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Janssen Pharmaceutica (Pty) Ltd.
15th Road, Halfway House, 1685.
© JPH (Pty) Ltd.
DATE OF PUBLICATION OF THIS PACKAGE INSERT
21 January 1983.
Code No.: 023373
Updated on this site: November 2002 Source: Pharmaceutical Industry
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